Are EMA MAs the same as UK MHRA MAs?
No.
European Marketing Authorisations (EMA) Marketing Authorisations (MAs) are issued by the EMA under the Centralised Procedure (CP) process. Once granted, this enables the MAH to market and distribute medicines within all EU member states. EMA CP MAs apply in Northern Ireland only from 1 st January 2021.
All pre-existing UK CP MAs have been ‘grandfathered’ by MHRA into GB MAs where the medicine is supplied to GB. Refer to MHRA for guidance.
Medicines that were issued in EU member states before EMA was formed may require two additional processes – De-Centralised Process (DCP) and Mutual Recognition (MR) – to register medicines across the EU.
From 1 st January 2021 UKNI and GB are aligned but not part of the DCP/MR processes operated by the EU. MAHs should seek guidance from MHRA on how to these types of MA apply.